LBL-525 Rev A SOZO IFU – August 2017 Page 1 LBL-525 REV A SOZO Instructions For Use ImpediMed –...

ImpediMed – August 2017 Page 1 LBL-525 REV A

SOZO

Instructions For Use


ImpediMed Limited ABN 65 089 705 144

Unit 1 50 Parker Court Pinkenba Qld 4008 Australia

Phone: + 61 7 3860 3700

Fax: + 61 7 3260 1225

Email: [email protected]

Website: http://www.impedimed.com/

EC REP

MediMark Europe Sarl

11 rue Emile ZOLA,

B.P. 2332, 38033 Grenoble Cedex 2

France

0086

For EU Customers: All products at the end of their life may be returned to ImpediMed for recycling.

For patent(s) and/or patent application(s) see: https://www.impedimed.com/patents/

For assistance with product set up please review the help videos at https://help.hellosozo.com. For other assistance, or to report product issues, please contact ImpediMed by email at [email protected] or by phone at + 61 7 3860 3700.

Unique Device Identifer SOZO device:

- B277272700011 SOZOthrive L-Dex module

- B277SOZOTHRIVE0 SOZOpro Body Composition module

- B277SOZOPRO0


Contents

Minimum Requirements .............................................................................................. 5 Tablet .............................................................................................................................................. 5

SOZO App ...................................................................................................................................... 5

Introduction ................................................................................................................. 6 The SOZO Device .......................................................................................................................... 6

Bioimpedance Spectroscopy (BIS) ................................................................................................ 6

Components of the SOZO System ............................................................................. 7

Safety Instructions ...................................................................................................... 8 Signs and Symbols ......................................................................................................................... 8

Intended Use .................................................................................................................................. 9

Contraindications ............................................................................................................................ 9

Warnings ........................................................................................................................................ 9

Precautions................................................................................................................................... 10

Use and Storage Conditions ........................................................................................................ 11

Environmental Operating Conditions ........................................................................................... 11

Environmental Transport and Storage Conditions ....................................................................... 11

Location for Use ........................................................................................................................... 12

Setting Up the SOZO Device and Stand .................................................................. 13

Setting Up the SOZO Device without Stand ............................................................ 14 Step 1: Connecting SOZOtouch and SOZOstep.......................................................................... 14

Step 2: Connecting the Tablet Stand ........................................................................................... 14

Step 3: Connecting Power Supply ............................................................................................... 14

SOZOhub installation ................................................................................................ 16

Pairing Tablet and SOZO App to SOZO System ..................................................... 17 Step 1 ........................................................................................................................................... 17

Step 2 ........................................................................................................................................... 17

Step 3 ........................................................................................................................................... 17

Initial setup of SOZO app ............................................................................................................. 17

Pairing the SOZO app with the SOZO system ............................................................................. 19

Preparing the patient ................................................................................................ 21 Standing vs. Seated positions ...................................................................................................... 21


Optimal readings .......................................................................................................................... 21

Standing Position ......................................................................................................................... 21

Seated position ............................................................................................................................. 22

Using the SOZO App ................................................................................................. 23 Overview ....................................................................................................................................... 23

Start-up ......................................................................................................................................... 23

Logging In ..................................................................................................................................... 23

Creating/Accessing Patient Profiles ............................................................................................. 25

Taking Measurements .................................................................................................................. 27

Weight Entry ................................................................................................................................. 29

Foot Placement ............................................................................................................................ 30

Hand Placement ........................................................................................................................... 30

Measurement Time ...................................................................................................................... 31

Cole Plots ..................................................................................................................................... 31

Viewing Historical Measurements and Patient Trending ............................................................. 33

Changing Device Settings ............................................................................................................ 34

Selecting SOZO device within the SOZO app ............................................................................. 35

Logging out ................................................................................................................................... 35

Indications for Use .................................................................................................... 36 SOZOthrive for Lymphedema ...................................................................................................... 37

SOZOthrive Module Results ......................................................................................................... 38

SOZOpro for Body Composition Measurements .......................................................................... 39

SOZOpro Module Results ............................................................................................................ 39

Personal Data ............................................................................................................ 41

Care and Maintenance .............................................................................................. 42 Care of the Product ...................................................................................................................... 42

Self-Test Function ........................................................................................................................ 42

Repairs ......................................................................................................................................... 42

Technical Support ........................................................................................................................ 43

Accessories .................................................................................................................................. 44

SOZO Product Warranty ........................................................................................... 45

Regulatory Statement ............................................................................................... 46

Product Specifications.............................................................................................. 47

Safety and Electromagnetic Compatibility (EMC) Information .............................. 48


Minimum Requirements

Tablet

The Samsung Galaxy Tab A (model SM-T580) will be provided to operate the SOZO device. For more product details, please review www.samsung.com or the tablet’s User Guide. Note: The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by ImpediMed is under license. Other trademarks and trade names are those of their respective owners.

SOZO App

The supplied tablet is preloaded with ImpediMed’s SOZO app for Android. The tablet and app will need to be paired via bluetooth to the SOZO device at initial setup. The app must also have network access over Wi-Fi® to the SOZOhub software to function.


Introduction

The SOZO Device

SOZO: A bioimpedance spectroscopy device for use on human patients, utilizing ImpediMed’s patented BIS technology in a user-friendly format to allow quick and accurate measurement of fluid levels. This can be used as an “early warning” monitor for determining changes in the fluid status of patients with fluid management problems.

Bioimpedance Spectroscopy (BIS)

Bioimpedance spectroscopy (BIS) is the only non-invasive technology available that has the potential to accurately measure body water volumes. BIS mode measures bioimpedance parameters over a frequency range of 3 - 1000 kHz with 256 data points. Comparison of the data collected within that frequency range enables calculation of extracellular, intracellular and total body water. With additional patient-specific data, further calculations can be made to determine other body composition results. On-screen graphs also display the measured data in the form of a Cole plot. The SOZO device and SOZOthrive module offers rapid, non-invasive, inexpensive comparison of impedance ratio’s between normal limbs and limbs at risk of lymphedema. The instruments also enable long-term patient monitoring and provide reports to support clinical and research practices.


Components of the SOZO System

SOZO by ImpediMed is made up of the following product components and accessories:

SOZOsupport (1)

SOZOtouch (2)

Handplate (3)

SOZOstep (4)

Footplate (5)

Power Adaptor and cord (6)

SOZOconnect cable (7)

Tablet holder (8)

Tablet including the SOZO app (9)

Screws and hex key for stand (10)


Safety Instructions

Signs and Symbols

The warning signs and the symbols below are listed in order to use this product safely and correctly as well as to prevent risk and injury to you and others. The meanings of the signs are as follows:

Symbol Definition

Indicates matters in which bodily harm or material damage or incorrect measurements may arise as a result of incorrect handling.

What you should NOT do.

An action that must be followed.

Follow instructions for use.

For EU Customers: All products at the end of their life may be returned to ImpediMed for recycling.

This device is rated BF as per IEC60601-1. This device meets the standard IEC60601-1-2.

This is a Class 2 medical device.

IP21 Protected from touch by fingers and objects greater than 12 millimeters. Protected from condensation.


Intended Use

SOZO is a medical device, intended for clinical use by operators who have read this manual. This device is intended for use, under the direction of the operator, for the noninvasive monitoring and management of fluid levels in patients. This includes use under direction of a physician in patients with fluid management problems in a variety of medically accepted clinical applications. For taking L-Dex® measurements in the clinical assessment of lymphedema, SOZO is specifically indicated for:

A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.

The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated. SOZOhub PC software – a PC software package that is intended to be used only with the ImpediMed SOZO device for uploading data on to the PC from the SOZO device, processing and analyzing of bioimpedance measurements.

The SOZO app is a software application intended to run on the supplied tablet and provides the main user interface for the system.

The SOZO device and SOZO app are used in conjunction with SOZOhub, a network-connected database system that securely stores patient data that is primarily accessed by the app.

Contraindications

The SOZO device should not be used by:

Patients with active implanted medical devices, e.g. cardiac pacemakers, defibrillators or patients connected to electronic life support devices.

Patients undergoing external defibrillation.

Warnings

Pregnant Patients:

While the use of bioimpedance technology in pregnant patients has been shown to have had no adverse effects, the SOZO device has yet to be clinically validated for use with that population group.


Precautions

Ensure that you have read and understood this entire instructions for use document before using the SOZO device. No other specific skill or training is required to take readings using the device.

Do not allow the SOZO device to come in contact with any liquids.

Only use the power adaptor that is supplied with this device. The use of any other power adaptor may expose the patient to the risk of electrocution.

Do not use or operate the device in the presence of strong electromagnetic fields. This Medical Device may interfere with other Medical Devices in its vicinity.

Devices or other sources can potentially cause interference problems:

Example 1: heat from a radiant heater. Example 2: moisture from a nebuliser.

Keep away from small children or animals. Strangulation due to cables may occur and small parts may be inhaled or swallowed.

Avoid using on subjects with metal allergies. Allergic reactions may be caused by the stainless steel used in the electrodes of this device.

Avoid using accessories, detachable parts and materials not described in the instructions for use, interconnecting this device with other equipment not described in the instructions for use, or modifying this device in any way.

The use of accessories, transducers, and cables other than those specified may result in increased Emissions or decreased Immunity of the SOZO device.


Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the SOZO system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

The effects of degraded sensors and electrodes, or loosened electrodes, can degrade performance or cause other problems.

Ensure that all data collected from the SOZO device is assessed under supervision of a physician when managing a chronic disease.

The SOZO device has a maximum weight capacity of 170 kg (375 lbs). Do not use the SOZO device in a standing position if patient weight exceeds 170 kg (375 lbs).

The SOZO device is intended for indoor use only. Do not use outdoors.

Use and Storage Conditions

Environmental Operating Conditions

The SOZO device must be operated in the following conditions:

A temperature range of +5°C to +40°C (+41°F to +104°F)

A relative humidity range of 15% to 93%, non-condensing

An atmospheric pressure range of 700 hpa to 1060 hpa

The SOZO device has been validated against applicable electrical safety standards for use in both clinical and home environments.

Environmental Transport and Storage Conditions

The SOZO device must be transported and stored in the following conditions:


-25°C (-13°F) without relative humidity control and +70°C (158°F) at a relative humidity up to 93%, non-condensing.

If the unit has been stored at the extremes of these temperature ranges, please allow it to return to within its operating temperature conditions (approximately 35 minutes) before installing or using.

Location for Use

Do not place device on any object or material made of metal, other than the SOZOsupport footplate and handplate.

The SOZO device should not be used adjacent to or stacked with other equipment and, if adjacent or stacked use is necessary, the SOZO device should be observed to verify normal operation in the configuration in which it will be used.

Using the SOZO device on carpet may cause static electricity, which could damage the equipment. If installing the SOZO device on carpet is unavoidable, please use the SOZOsupport stand, or an antistatic mat.

Various environmental factors environment may interfere with device performance including: the effects of lint, dust, light (including direct sunlight), as well as pets, pests, or children.

Ensure that you have read and understood this entire instructions for use document before using the SOZO device. No other specific skill or training is required to take readings using the device.

Surface temperature may exceed 47° C (117° F) in normal use. Do not use SOZO device if it is hot to the touch. Disconnect the device by unplugging the power adaptor and call ImpediMed Technical Support.


Setting Up the SOZO Device and Stand

Please refer to LBL-503 SOZO™ QUICK START GUIDE, contained in the same box as the tablet, or alternately available at www.hellosozo.com. Please be aware, as you proceed through installation, of the following;


Ensure that the connector cable is plugged in to both hand and foot plates before connecting the power supply. If the SOZO device must be moved, please ensure the power supply is disconnected before moving or uninstalling the system.

When plugging the power cord in, the system will automatically run a self-test to ensure functionality. Do not touch the stainless steel electrodes when a self-test is running.

For more information on setting up the SOZO system with stand, please visit www.hellosozo.com or contact ImpediMed technical support (contact details on page 43 of this guide).


Setting Up the SOZO Device without Stand

Step 1: Connecting SOZOtouch and SOZOstep

Components required:

SOZOtouch assembly

SOZOstep assembly

SOZOconnect cable

Connect SOZOtouch to SOZOstep with the connector cable. (NOTE: the connector cable port is identical on both the hand plate and foot plate.)

Place the SOZOtouch assembly on a level surface and at a comfortable height to use while sitting. (e.g. table or desk).

Place the SOZOstep assembly on a level surface beneath/in alignment with SOZOtouch. Ensure that SOZOstep is positioned in such a way that the power supply can be easily connected and disconnected.

Step 2: Connecting the Tablet Stand


Tablet

Tablet stand

SOZOtouch assembly

Confirm that the SOZOtocuh assembly is stationary and on a level surface. Place the tablet holder onto SOZOtouch with the ledge of the holder facing the SOZOtouch stainless steel electrodes. (NOTE: for clinical use, the tablet holder can be reversed with the ledge of the holder facing away from the electrodes) Place the tablet onto the ledge of the tablet stand.

Step 3: Connecting Power Supply


SOZOstep


Power supply cable

Locate the power supply port on the back of the SOZOstep assembly and plug the corresponding end of the power supply cable into that port.

Take the remaining end of the power supply cable and plug it into the nearest wall outlet. The SOZO device may be safely turned off by unplugging the power adaptor.


Ensure that the connector cable is plugged in to both SOZOtouch and SOZOstep assemblies before connecting the power supply. If the SOZO device must be moved, please ensure the power supply is disconnected before moving or uninstalling the system.

When plugging the power cord in, the system will automatically run a self-test to ensure functionality. Do not touch the stainless steel electrodes when a self-test is running.

For more information on setting up the SOZO system without the SOZOsupport stand, please visit www.impedimed.com or contact ImpediMed technical support (contact details on page 43 of this guide).

Setup Complete


SOZOhub installation

While setting up the SOZO device, the SOZOhub software will also need to be installed on a network-connected computer.

SOZOhub is ImpediMed’s SOZO management system and database software that will support your SOZO use, store patient measurement data, and interface with the SOZO app. Please refer to the SOZOhub instructions for use on installation and set up.

SOZOhub installation, and creation of at least one user account, must be completed prior to setting up the SOZO app.


Pairing Tablet and SOZO App to SOZO System

Step 1

Press the button on the back of the SOZOtouch assembly to enable Bluetooth on the SOZO device.

Step 2

Locate the Settings section on the tablet and enable Bluetooth. Once Bluetooth is enabled, select ImpediMed SOZO from the list of available devices. (*Note: Bluetooth must be enabled first on the SOZO device for the tablet to find it; the SOZO device will be identified by the SOZO device serial number (SOZO-xxxxxxxxxx) when the tablet scans for nearby Bluetooth-enabled devices.)

Step 3

Initial setup of SOZO app

The tablet shall come with the ImpediMed SOZO app pre-installed. If the app is not installed, please contact ImpediMed to walk through the download and installation process.

With the SOZO app installed, tap on the icon to start it as you would any other app. This will bring you to the login screen:


For first-time setup of any SOZO system in the facility, you will need to click on “Set Connection Path” to link the SOZO app to the SOZOhub database on your hospital server.

The path is a fixed IP address that links to the server directory where the database is stored and requires authentication before you can proceed.


Clinician accounts are not created through the SOZO app. Accounts are created through the SOZOhub management system and database. SOZOhub must first be set up on an accessible network as part of SOZO installation, and a user account created, to proceed further with set up of your SOZO system. Please refer to the SOZOhub instructions for use to create new users to access your SOZO system.

Pairing the SOZO app with the SOZO system

- During first-time setup, the app will need to be paired with the SOZO system. Once the user account has been created and you have logged in to the dashboard screen, click on ‘Pair Device’:

The app should then automatically connect with the SOZO device that was paired through Bluetooth earlier. This can be confirmed by pressing the ‘Settings’ button which will take you to the overall settings for the device.


Note: ImpediMed recommends keeping your SOZO device together with the app and tablet paired to it. The app and tablet may pair to other devices, but will only control measurements from the device that is identified in the settings tab. Once the SOZO device is shown on the settings tab, you are ready to take measurements.

Setup Complete


Preparing the patient

All individuals taking measurements on a SOZO device should:

1. Remove all jewellery

2. Remove stockings or socks

For SOZOpro measurements, the patient should observe the following preparation tips to ensure the most accurate reading:

1. Empty their bladder prior to measurement start

2. Avoid exercise 2 hours prior to the reading

3. Avoid caffeine 2 hours prior to the reading

4. Avoid alcohol 12 hours prior to the reading

*Note: It is preferable if the measurements are undertaken under similar conditions, e.g. time of day, activity levels, and food and fluid intake.

*Note: Please also read the Indications For Use section for any indication-specific instructions.

Standing vs. Seated positions

The SOZO system has been designed to accommodate patients who may not be able to stand. The SOZO system setup provides instructions on how to configure the system for both standing and seated positions. It is strongly recommended that patient’s should always take readings from the same position to enable accurate comparisons of fluid levels.

Optimal readings

For best results when taking a reading from a standing position, the subject should stand at rest for a few minutes prior to taking a measurement.

Similarly, when taking a reading from a seated position, the subject should be seated for approximately a few minutes prior to taking a measurement.

Standing Position

When standing on the SOZO device, ImpediMed strongly recommends using the SOZO stand provided with the system.


The patient should:

Distribute their body weight evenly on both feet.

Keep their arms relaxed while their hands make contact with the electrodes. The patient’s elbows should not be in contact with their torso as that can affect measurement quality.

Seated position

Do not use a metal table or chair. The patient should:

Sit well back in chair with body in balance and shoulders rolled back.

Distribute body weight evenly on both hips.

Bend knees at a right angle, plus or minus 10 degrees.

Keep their arms relaxed while their hands make contact with the electrodes. The patient’s elbows should not be in contact with their torso as that can affect measurement quality.


Using the SOZO App

Overview

The SOZO device utilizes an ImpediMed-supplied Samsung Galaxy Tab A tablet to control the SOZO device operation. The app will require access to your facilities’ intranet to store patient data.

The app is comprised of five major sections:

1) Login screen, where users can log in to access the Dashboard screen

2) The Dashboard screen, which lists available patients and allow creation of new patients, long with the entry of their demographic data

3) Patient Profile, which allows measurements to be taken for a given patient, and historical records reviewed

4) Device Settings

The following section will describe access and use of the app.

Start-up

Logging In

Tap the SOZO app icon to launch. This will take you to the login screen; use your user name and password, set up through SOZOhub, to access the app.


After logging in, you wil be taken to the Dashboard screen:


Creating/Accessing Patient Profiles

After initial setup, patients will need to be added to the database in order to use the SOZO device. All new patients can be added through the Dashboard screen after login. Note that patients do not have their own login, but profiles are controlled through the clinician’s log in. To ensure patient privacy, it is strongly recommended that the patient not handle the tablet during measurements. At the Dashboard screen, patient profiles may be located by tapping the button marked ‘New Patient’. The app will take you through the patient setup process to record patient information and demographics, including:

Name Local Patient Identifier Patient email contact:

Date of Birth and Sex:


Weight and Height:

After tapping ‘Create Account’ the app will take you to the patient’s summary screen.


To create additional patients, return to the Patient Dashboard, tap on ‘New Patient’ and repeat the process.

Taking Measurements

Your SOZO device may support multiple measurement types including detection of lymphedema and various body composition outputs. Each of these applications, along with


indication-specific information and the reports that SOZO will provide, are discussed in greater detail later in this user guide. From the Clinician List Screen, select the patient to be measured:

This will take you to the patient’s summary screen (see screen above). From that screen, tap the ‘Measure’ button. This will take you to the ‘Select Measurement Type’ screen: The ‘Select Measurement Type’ screen may have different options for measurement types, depending on the modules that have been enabled for your site.

Select the appropriate measurement type. For more information on measurement types, review the ‘Indications for Use’ sections later in this document.


Weight Entry

The app will require the patient’s current weight prior to each reading. Enter the patient’s current weight (using their most recent weight measurement if weight was not taken during their visit to your facility) to proceed:


The app will then remind clinician and patient about measurement steps:

Foot Placement

Confirm that the SOZOstep assembly is stationary and on a level surface. Place feet (no stockings/pantyhose or socks) onto SOZOstep and locate heel recesses. Make sure that each foot is flat and in full contact with each electrode plate. (*Note: there are two electrode plates for both the left and right foot.)

Hand Placement

Confirm that the SOZOtouch assembly is stationary and on a level surface. Place both hands (completely flat) onto the SOZOtouch with thumbs securely wrapped around the corners of both recesses. Make sure each hand is flat and in full contact with each electrode plate. (*Note: there are two electrode plates for both the left and right hand.)


Surface temperature may exceed 47° C (117° F) in normal use. Do not use SOZO device if it is hot to the touch. Disconnect the device by unplugging the power adaptor and call ImpediMed Technical Support.

Please read the section on Intended Use and Precautions before making measurements with the SOZO device.

Measurement Time

The SOZO device will need approximately 30 seconds to take a complete measurement. Audible clicking noises will be heard as the measurement is taken. These clicking noises indicate that the process is working correctly. Once the measurement is complete the results for the measurement type will display on the dashboard.

Cole Plots

The SOZO app will then display Cole Plots after the measurement is taken and allow the user to determine if an adequate reading was taken. The Cole plot, represented on the graph by a solid red semi-circular line, gives a visual representation of the measurement and is used to indicate a valid measurement has been taken.


Individual data points are also represented on the graph. If they show a trend that is consistent with the Cole Plot, this indicates a valid measurement has been performed, and the results can be accepted. If data points are scattered, or a semi-circular line is not formed, this indicates that a valid measurement has not been performed. The measurement should then be rejected, and a new measurement taken. During the brief measurement period, the patient will need to stay still to ensure an accurate reading is taken. Errors may be introduced into the reading if the patient does not stay still (e.g. shifts their hands, feet, or torso), or loses contact with the electrodes. Note that Cole plots are also shown when reviewing historical results. Determination of adequacy can only be made at the time the measurement is taken. Examples of good and bad Cole plots follow:


Viewing Historical Measurements and Patient Trending

To access patient records and review their measurements, select the desired patient from the patient list in the Dashboard:

From the patient screen, the patient’s history of measurements can be obtained from the ‘Results’ section:


From this screen, select which reading type you want to review. You may be able to select from up to two options (SOZOthrive or SOZOpro) depending on the modules that have been enabled for your site. :

The system will record and highlight those days on which records were taken. Tapping on highlighted days will give you the option to select which reading was taken. Selecting a given reading will take you to the output screen for that reading. All output screens will be accompanied by historical trending for the selected patient. Note: patient measurement records may also be accessed through SOZOhub if the tablet is unavailable. Other than the SOZO app, no data is stored on your tablet. All clinician and patient data are stored in SOZOhub.

Changing Device Settings

Select the Settings button from the Dashboard screen. The Settings section provides access to commonly needed configuration and maintenance functions.


From this page, the user can update the application on the tablet or the firmware on the SOZO device, change measurement units, and update the device status. *Note: Measurement units are expressed in metric or imperial units of measure and are changed individually.

Selecting SOZO device within the SOZO app

The app will initially be paired to a SOZO device during first setup of the system at your facility. This will not need to be repeated for any new users added through SOZOhub. The process may be repeated for any new SOZO devices, and will need to be repeated if either the tablet or system have to be replaced. Please note that the app can only select and work with one SOZO device at a time.

Logging out

To log out, tap the ‘Logout’ button accessible from the Dashboard screen. A pop-up will ask to confirm the logout at which point the app will return to the login screen. Please note that the app will time out 60 minutes after login. To continue using the app, the user will first have to log out following the process described above, and then log back in.


Indications for Use

The SOZO device is currently configured to provide measurements for three types of measurements as detailed further below:

1) The SOZOthrive measurement aids a clinician in the assessment of unilateral lymphedema in a patient by assessing L-Dex® scores. The specific indication is below:



2) The SOZOpro measurement provides a body composition analysis of a healthy individual.


SOZOthrive for Lymphedema

Indications for use



Instructions for use Ensure you have read and understood the instructions for use in preceding sections regarding setup, installation and use of the SOZO app. All warnings, contraindications and precautions apply. In addition, please consider the following when using SOZO to take L-Dex measurements on a patient:

For patients who cannot effectively separate their inner thighs, it may be necessary to place insulating material (e.g. dry clothes) between them. Ensure the patient’s upper arms and elbows are not in contact with their torso.

Prior to taking a measurement, the patient’s profile will need to be updated to reflect the following items:

- Body element: select whether the arms or legs are at risk of lymphedema.

- Risk limb: select whether the right or left limb is at risk.

- Limb dominance: select whether the left arm/right arm or left leg/right leg dominant.

Please ensure the correct selections have been made as incorrect readings will affect the L-Dex calculations.


SOZOthrive Module Results

The Lymphedema Index (L-Dex®) The results are used to calculate a Lymphedema Index or L-Dex value. This value is derived from the ratio of the impedance determined for the unaffected limb and the at-risk limb. Research has been performed to ascertain the normal range of L-Dex values in healthy patients. These normal ranges are presented in the analysis screens to assist in patient evaluation.

SOZOthrive Module Results This module will display the current L-Dex value on a scale to see if the patient's L-Dex value resides within or outside the normal range of values for a healthy person. Note: L-Dex values of –10 and beyond (-11,-12 etc.) are commonly associated with procedural errors. In this case a warning will be displayed showing the reading is out of range. Note: L-Dex values greater than 10 may indicate the early signs of lymphedema and values that have changed +10 L-Dex units from baseline may also indicate early lymphedema. The L-Dex scale is a tool to assist in the clinical assessment of lymphedema by a medical provider.

Results Trend The results trend graph allows comparison between current readings and previous result(s), so that it is clear if the L-Dex value is increasing or decreasing over time.

Recommended Measurement Frequency ImpediMed recommends the following frequency of measurements for patients at risk of unilateral lymphedema: Pre-operative baseline Years 1-3: Every 3 months Years 4-5: Every 6 months Year 6+: Annually


SOZOpro for Body Composition Measurements

Indications for Use When using the SOZO device’s SOZOpro module for body composition measurements, the following indication for use applies: The SOZO system is a bioimpedance spectroscopy device intended to estimate the following body composition parameters:

Total Body Water (TBW), Extracellular Fluid (ECF), Intracellular Fluid (ICF) Fat-free Mass (FFM), Fat Mass (FM) Active Tissue Mass (ATM), Extracellular Mass (ECM), Basal Metabolic Rate (BMR) Skeletal Muscle Mass (SMM), Phase Angle, Body Mass Index (BMI) Hydration Index (Hy-Dex) Analysis The device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display Cole plots as well as subject weight, age and gender. The device is intended to be used only on healthy patients, who wish to have their body composition estimated in the home or clinical environment.

Instructions for use Ensure you have read and understood the instructions for use in preceding sections regarding setup, installation, patient preparation and use of the SOZO app. All warnings, contraindications and precautions apply.

SOZOpro Module Results

At the conclusion of a measurement, the app will present a screen containing a wide range of body composition information in your preferred units of measure (defined in the settings section):

Fluid Status: Total Body Water (TBW) Extracellular Fluid (ECF) Intracellular Fluid (ICF)

Total Body Composition Fat Free Mass (FFM) Fat Mass (FM)


% of weight Metabolic Report

Active Tissue Mass (ATM) Extracellular Mass (ECM) Basal Metabolic Rate (BMR)

Other Skeletal Muscle Mass Phase Angle Body Mass Index (BMI) Weight

Hydration Index (Hy-Dex) Analysis

Recommended Measurement Frequency Measurement frequency should be based on clinical evaluation of the patient’s monitoring needs. Daily, weekly or monthly readings may be appropriate using your best clinical judgment.


Personal Data

Read our privacy policy located at

https://www.impedimed.com/privacy-policy/


Care and Maintenance

Care of the Product

When not in use the SOZO device may remain set up and does not need to be uninstalled. If storage is desired, always keep the SOZO device in its original packaging.

The external enclosure of the SOZO device should be cleaned between each use with non-bleach based disinfecting agents such as isopropyl alcohol 70% or Peridox® Concentrate Sporicidal Disinfectant and Cleaner. Cleaning/disinfection should be performed according to manufacturer’s instructions for use and your facilities’ policy. ImpediMed does not recommend the use of bleaching agents to clean/disinfect the SOZO system.

The tablet may require cleaning and disinfection as well. For the Samsung Tablet provided with your SOZO unit, ImpediMed recommends the use of protective disposable tablet sleeves, to be used and replaced as per your facilities policy. The use of protective sleeves prevents the need to use potentially damaging chemicals on the tablet itself.

The SOZO device should not be subjected to ingress of liquid or liquid spillage, impact and excessive heat (direct exposure to sunlight). This can cause damage to the device or harm to the patient or give an incorrect reading. The SOZO device should be used in a dry environment.

Contact ImpediMed or an authorised agent for repair.

Self-Test Function

If you wish to ensure that the system is operating correctly, a self-test may be performed from the Device Settings Screen. ImpediMed recommends that the self-test be performed at the start of the day.

Do not touch the stainless steel electrodes when a self-test is running.

Repairs

There are no user-repairable electronic parts within the SOZO device. Please contact ImpediMed or an authorised agent should service or repair of the SOZO device be required. Do


not attempt to use the SOZO device if it does not appear to be functioning correctly or is in need of repair.

Technical Support

Australia

Phone: + 61 7 3860 3700

Fax: + 61 7 3260 1225

USA

Phone: (877) 247-0111 Option 3

Fax: (760) 804-9245

SOZO Website: www.hellosozo.com

SOZO Help Webpage: https://help.hellosozo.com

SOZO Help Email: [email protected]


Accessories

The following accessories are available from ImpediMed. Please contact ImpediMed or an authorised agent to purchase replacement parts.

Description ImpediMed Part Number

SOZOstand pedestal 2727100

Tablet 2727129

Tablet sleeves (Qty 10) 2726100

Medical Grade power supply (tablet) 2726500


SOZO Product Warranty

To review ImpediMed’s warranty for the SOZO product line, please refer to the following link: www.hellosozo.com/warranty


Regulatory Statement

FCC ID: QOQBT121 This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. This device complies with the R&TTE Directive.


Product Specifications Drive AC current 200 micro Amps RMS at a variable frequency of 3 kHz to

1000 kHz.

Frequency Scan 3 to 1000 kHz (256 frequencies)

Scan speed: 30 seconds to complete a full scan.

Power Supply 24V DC, 1.0A

Dimensions Hand Plate L=330mm, W=180mm, D=170mm

Foot Plate L=450mm, W=320mm, D=40mm

Effective Radiated Power (BT Module)

-18 dBW

Weight 1 kg

Data Displayed Cole resistance-reactance plot, lymphedema Index (L-Dex®) value

Environmental transport, and storage conditions

- 25 °C without relative humidity control; and

+ 70 °C at a relative humidity up to 93%, non-condensing;

Environmental operating conditions

a temperature range of + 5 °C to + 40 °C

a relative humidity range of 15% to 93%, non-condensing; and an atmospheric pressure range of 700 hpa to 1060 hpa.

Device (IEC 60601-1) electrical classification

Type BF

Electromagnetic Compatibility

Meets the requirements of IEC 60601-1-2 and 60601-1-11.

Minimum service life of device and accessories

Minimum service life and associated warranty of parts and accessories is one year.


Safety and Electromagnetic Compatibility (EMC) Information

Guidance and manufacturer’s declaration – electromagnetic emissions

The SOZO device is intended for use in the electromagnetic environment specified below. The customer or the user of the SOZO device should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1 The SOZO device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B The SOZO device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions

IEC 61000-3-2 Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

Guidance and Manufacturer’s Declaration – Immunity


Immunity test 4th Edition

Test Levels Compliance level Electromagnetic

environment – guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±8kV Contact

±15kV Air

±8kV Contact

±15kV Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

IEC 61000-4-4

±2kV Mains

±1kV I/Os

100 kHz Repetition Freq

±2kV Mains

±1kV I/Os

100 kHz Repetition Freq

Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

±1kV Differential

±2kV Common

±1kV Differential

±2kV Common Mains power quality should be that of a typical commercial or hospital environment.

Voltage Dips/Dropout

IEC 61000-4-11

>95% Dip for

0.5 Cycle

60% Dip for

5 Cycles

30% Dip for

25 Cycles

>95% Dip for

5 Seconds

-----------------------

0% Ur for

>95% Dip for

0.5 Cycle

60% Dip for

5 Cycles

30% Dip for

25 Cycles

>95% Dip for

5 Seconds

-----------------------

0% Ur for

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SOZO device requires continued operation during power mains interruptions, it is recommended that the SOZO device be powered from an uninterruptible power supply or a battery.


0.5 cycle

@ 0, 45, 90, 135, 180, 225, 270 and 315 degrees.

0% Ur for 1 cycle

0.5 cycle

@ 0, 45, 90, 135, 180, 225, 270 and 315 degrees.

0% Ur for 1 cycle Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

30A/M

50 or 60 Hz

30A/M

50/60 Hz Power frequency magnetic fields should be that of a typical commercial or hospital environment.

NOTE Ur is the a.c. mains voltage prior to application of the test level.



Immunity test 4th Edition

Test Levels Compliance level Electromagnetic environment – guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms (Outside ISM)

6Vrms (In ISM and amature Bands)

150 kHz to 80 MHz

10 V/m

80 MHz to 2.7 GHz

80 % AM at 1 kHz

(V1) = 3Vrms

(V2) = 6Vrms

Portable and mobile communications equipment should be separated from the SOZO by no less than the distances calculated/listed below:

D=(3.5/V1)(Sqrt P)

D=(12/V2)(Sqrt P)

D=(12/E1)(Sqrt P)

80 to 800 MHz

D=(23/E1)(Sqrt P)

800 MHz to 2.7 GHz

where P is the max power in watts and D is the recommended separation distance in meters.

Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1).

Interference may occur in the vicinity of equipment containing a transmitter.



Test Frequency (MHz)

Band (MHz)

Service Modulation Maximum

Power (W)

Distance (m)

Immunity Test Level (V/m)

385 380-390 TETRA 400 Pulse

Modulation 18Hz

1.8 0.3 27

450 430-470 GMRS 460,

FRS 460

FM ± 5 kHz

deviation 1KHz sine

2 0.3 28

710

704-787 LTE Band 13,

17

Pulse Modulation

217 Hz 0.2 0.3 9 745

780

810

800-960

GSM 800/900, TETRA 800, iDEN 820,

CDMA 850, LTE Band 5

Pulse Modulation

18 Hz 2 0.3 28 870

930

1 720

1700-1990

GSM 1800; CDMA 1900; GSM 1900;

DECT; LTE Band

1,3,4,25; UMTS

Pulse Modulation

217Hz 2 0.3 28 1 845

1 970

2450 2400-2570

Bluetooth, WLAN,

802.11 b/g/n, RFID 2450, LTE Band 7

Pulse Modulation

217 Hz 2 0.3 28

5240

5100-5800

WLAN 802.11 a/n

Pulse Modulation

217 Hz 0.2 0.3 9 5500

5785

Recommended separation distances between portable and mobile RF communications equipment and the SOZO device


The SOZO device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SOZO device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SOZO device as recommended below, according to the maximum output power of the communications equipment.

Max Output Power

(Watts)

Separation (m)

150kHz to 80MHz

Non-ISM D=(3.5/V1)(Sqrt P)

Separation (m)

150kHz to 80MHz

ISM

D=(12/V2)(Sqrt P)

Separation (m)

80 to 800MHz

D=(12/E1)(Sqrt P)

Separation (m)

800MHz to 2.7GHz

D=(23/E1)(Sqrt P)

0.01 0.116667 0.12 0.12 0.23

0.1 0.368932 0.379473 0.379473 0.727324

1 1.166667 1.2 1.2 2.3

10 3.689324 3.794733 3.794733 7.273239

100 11.66667 12 12 23

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